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Completed

NCT Number: NCT04250675

Intermittent Pneumatic Compression to Improve Revascularization Outcome

The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist

Indianapolis, Indiana, 46202, United States

About this study

Restenosis following revascularization procedures occur frequently and as early as 3 months after the intervention. There is an urgent need for adjunctive therapies that aid in the improvement of tissue blood flow and consequently relieve pain and improve functional capacity in these patients. It has been previously shown that exposure to IPC enhances leg blood flow to collateral-dependent tissues. In this study, subjects who have undergone nonsurgical revascularization will be randomly assigned to two groups: IPC or placebo pump. Subjects will receive a commercially available IPC device (Art Assist, ACI Medical, San Marcos, CA) and will apply the treatment at home for 2 hours daily over 3 consecutive months. At 3 time points (pre, 1 and 3 months post procedure) assessments will be performed (hemodynamics, rest pain, calf muscle oxygenation during exercise, walking endurance and quality of life).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Scheduled for endovascular revascularization of one or both lower extremities.

Exclusion criteria

  • Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula)
  • Open and/or non-healing wounds in the areas covered by IPC cuff
  • Walking limited by a symptom other than PAD
  • Presence of any clinical condition that makes the patient unsuitable to participate in the trial
  • Concern for inability of the patient to comply with study procedures and/or follow-up

Treatment and study plan

Intermittent pneumatic leg compressions

Device

Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.

SHAM

Device

Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.

Primary outcomes

  1. Walking Endurance

    Time frame: Baseline and after 1 and 3 months of treatment

    Change in 6 Minute Walk Test from baseline to 3 months

Secondary outcomes

  1. Ankle-brachial Index (ABI)

    Time frame: Baseline and after 3 months of treatment

    Change in ABI from baseline to 3 months. A handheld 5-MHz Doppler ultrasound (Lumeon, McKesson) was used to obtain duplicate measurements of systolic pressures in the right posterior tibial artery, right dorsalis pedis artery, right brachial artery, left posterior tibial artery, left dorsalis pedis artery, and left brachial artery. The ABI of each leg was calculated by dividing the higher of the dorsalis pedis pressure or posterior tibial pressure by the higher of the right or left arm blood pressure

  2. Vascular Quality of Life Score (VascuQol)

    Time frame: Baseline and after 1 and 3 months treatment

    Change in scores for VascuQol Questionnaire from baseline to 3 months. Overall score range is 7-175; higher score means higher quality of life.

  3. Toe-brachial Index

    Time frame: Baseline and after 1 and 3 months of treatment

    Change in toe-brachial index from baseline to 3 months. A toe-brachial index (TBI) is a non-invasive test that measures the ratio of systolic blood pressure in the toe to the higher systolic pressure in the arm. A toe/digit pressure cuff is wrapped around the measured toe, and a senso is placed on the toe distally to the pressure cuff.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Roseguini, Bruno, PhD

Registry information

Official study title

Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2020
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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